US8968402B2 - ACL implants, instruments, and methods - Google Patents

Abstract

Systems for single tunnel, double bundle anterior cruciate ligament reconstruction include implant constructs and instruments. The implant constructs provide a combination of cortical fixation and bone tunnel aperture fixation. The implant constructs separate a graft into distinct bundles. The instruments are used to prepare shaped bone tunnels to receive the implant constructs and graft bundles. The instruments are also used to exercise and insert the ligament graft constructs. Methods for reconstructing the antero-medial and postero-lateral bundles of the anterior cruciate ligament may rely on a single femoral tunnel, single or double tibial tunnels, and one or more ligament grafts.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of:

U.S. Provisional Patent Application No. 61/548,467, filed Oct. 18, 2011, and is entitled: ACL IMPLANTS, INSTRUMENTS, AND METHODS.

The above-identified document is hereby incorporated by reference in its entirety.

BACKGROUND

The present disclosure relates to anterior cruciate ligament (ACL) repair surgery. More precisely, the present invention relates to implants, systems, methods of use and instruments for double bundle ACL repair, including securing an ACL graft with a cortical fixation device and separating the graft into multiple bundles with an aperture fixation device so as to approximate the natural bundles of an intact ACL. For example, the systems, apparatus, and methods disclosed herein may be applicable to tibial or femoral fixation of a doubled hamstring tendon graft. It is contemplated that the systems and methods set forth herein, or adaptations, may be useful in suspensory fixation applications beyond anterior cruciate ligament repair.

It is generally accepted in the field of orthopedic surgery that the anterior cruciate ligament does not heal itself after injury. Initial attempts at repair of this ligament resulted in nearly uniform failure of the ligament to stabilize the knee joint.

Over the course of the last four decades, practitioners have turned to methods of ligament reconstruction in attempts to restore knee stability and normal knee kinematics. Most surgeons have become proficient with a ligament reconstruction technique involving autograft or allograft replacement of the native ACL. Autografts, which are harvested from the patient's own body, may comprise bone-patellar tendon-bone (BPTB), hamstring tendon (HT), or occasionally quadriceps tendon (QT). Allografts, which are harvested from a donor, may comprise patellar tendon, quadriceps tendon, Achilles tendon, tibialis anterior tendon, hamstring tendons, or occasionally peroneal tendons. Any of these grafts may be placed so that it traverses the intercondylar notch and its ends rest within tibial and femoral bone tunnels.

Two important surgical factors in achieving a stable, fully functional, pain-free knee after ACL reconstruction are correct placement of the femoral and tibial tunnels, so that the ACL graft does not impinge the posterior cruciate ligament (PCL) or the roof of the intercondylar notch, and the use of slip-resistant, stiff, strong fixation for the ends of the graft.

Tibial and femoral bone tunnel placement has been a very controversial topic. Anterior placement of the femoral tunnel has become generally accepted as a technical cause of graft failure. Recently, after years of transtibial placement of the femoral bone tunnel, it has become increasingly popular to drill the femoral tunnel separately (i.e., through a medial arthroscopic portal). This may result in more anatomic placement of the femoral tunnel and improved graft orientation.

There are currently many options for graft fixation. Many surgeons who prefer BPTB grafts use interference screw fixation. However, among surgeons who prefer soft tissue grafts, a wide variety of fixation devices are used with little consensus as to what is best. Soft tissue graft fixation can be broadly divided into interference screw-based fixation, cortical fixation, and cross pin fixation.

Interference screw-based fixation of soft tissue grafts may be used in the femur and tibia. This type of fixation generates friction between the graft and the bone tunnel. Many surgeons who were originally trained in BPTB grafts continue to use this method of fixation when they use soft tissue grafts. Metal and bioabsorbable interference screws are currently available. However, there are no interference screws that have demonstrated bony ingrowth, which would be beneficial over the long term.

Cortical fixation may be preferred by surgeons who primarily use soft tissue grafts. A number of devices are known to take advantage of the innate strength of cortical bone. As early as 1966, German surgeon Helmut Bruckner described an ACL reconstruction technique in which a BPTB graft was secured by sutures to a button resting on the lateral aspect of the lateral femoral condyle. Other examples of cortical fixation devices include Endobutton™ (Smith and Nephew) and EZLoc™ (Biomet). Cortical fixation devices have been shown to have some of the highest pullout strengths of any soft tissue graft fixation device. In the femur, these devices may comprise an extracortical anchor attached to a fabric or suture loop. Such a device may be used by draping the graft over the fabric loop, supporting the anchor against the exterior cortical surface so that the graft is suspended within the tunnel, and securing the fabric loop to the anchor. In the tibia, cortical fixation may be achieved by stitching sutures to the free ends of the graft, placing a screw through the anterior tibial cortex, tying the sutures around the screw, and compressing the sutures against the cortex with a washer.

Cross-pin fixation has been gaining in popularity, at least in part because of the perception that it may provide secure fixation closer to the tunnel aperture than that provided by cortical fixation. Cross-pin fixation may be achieved by passing a pin across a bone tunnel close to the aperture and draping the graft over the pin where it crosses the tunnel.

Although there may be little evidence that aperture fixation provides greater stability than does cortical fixation, many surgeons prefer aperture fixation because it may avoid the so-called “bungee effect” of cortical fixation devices. This theory presumes that an ACL reconstruction spanning a longer distance between fixation points will have greater elasticity than an ACL reconstruction spanning a shorter distance. Fixation closer to the joint space may provide higher stability than remote fixation at the cortex because the distance across the joint space is much less than the distance between extracortical fixation points. However, a 2005 meta-analysis of stability after ACL reconstruction showed cortical fixation to be associated with the highest rates of ACL reconstruction stability for soft tissue grafts.

There may be biomechanical evidence that aperture fixation may lead to increased graft stiffness. On the tibia, distal cortical fixation of a soft tissue ACL graft may be stronger, stiffer, and more slip resistant than is aperture fixation with an interference screw alone. The use of an interference screw alone may cause tunnel widening and may prevent circumferential tendon-tunnel healing, which may result in inferior strength and stiffness at 4 weeks compared with cortical fixation. However, the insertion of a bone dowel alongside a tendon graft in the tunnel, in conjunction with distal cortical fixation, may prevent tunnel widening, increase stiffness, promote circumferential healing, and simplify revision surgery.

Aggressive, brace-free rehabilitation with early weight bearing may be safe following high-stiffness, slip-resistant fixation. The high stiffness provided by distal cortical fixation may reduce the graft tension required to restore stability and may lower graft tension during open-chain exercise. Reducing the graft tension without increasing anterior laxity requires high-stiffness fixation which also resists slipping and tension loss during aggressive rehabilitation. Whipstitch-post tibial cortical fixation was the first fixation method used successfully for quadrupled hamstring grafts. Simple interference screw fixation has had mixed results, while interference screw fixation combined with cortical fixation has shown very good results. Similarly, interference screw-based methods such as the Intrafix™ (DePuy Mitek) appear to be promising constructs on the tibial side. Although cross-pin fixation on the tibial side may be popular among surgeons, there is a paucity of clinical data pertaining to it, and the clinical series that have been published to date have shown mixed results.

Despite advancements in single bundle ACL reconstruction, a review of the literature demonstrates that between 10% and 30% of patients report persistent instability following single bundle ACL reconstruction surgery. Among single bundle ACL reconstructions, only 70% of KT1000 test results demonstrate a <2 mm side-to-side difference, with a failure rate of 5% to 10%. The return-to-sport rate for single bundle restorations is only 60% to 70%.

Anatomic studies reveal that the ACL has two functional bundles: the anteromedial (AM) bundle and the posterolateral (PL) bundle. The bundles are named according to their tibial insertion sites. With the knee in extension, the AM and PL bundles are parallel to each other and are oriented generally along the mechanical axis of the leg. When the knee is flexed to 90 degrees, the AM and PL bundles are crossed. This occurs because the PL bundle femoral insertion site is posterior to the AM bundle femoral insertion site when the knee is in extension, and anterior to the AM bundle femoral insertion site when the knee is flexed to 90 degrees. In other words, the AM bundle femoral insertion site rotates over the PL bundle femoral insertion site as the knee flexes. As a result, each bundle makes a unique contribution to knee kinematics at different knee flexion angles. In extension, the PL bundle tightens and the AM bundle relaxes, whereas in flexion, the AM bundle tightens as the μL bundle becomes lax. The AM bundle is the primary restraint against anterior tibial translation and the PL bundle tends to stabilize the knee in full extension, particularly against rotational loads.

Anatomic double bundle ACL reconstruction has some logical rationales in its favor and is supported by biomechanical studies. These studies suggest that conventional single bundle ACL reconstruction may successfully restore anteroposterior knee stability, but the reconstructed knee may be unable to resist combined rotatory loads. Cadaveric studies of double bundle knee reconstructions reveal a closer restoration of normal knee kinematics and better rotational stability. A closer restoration of normal knee kinematics may be associated with improved functional outcomes following ACL reconstruction.

Reciprocal tensile behavior has long been a quest of the surgeon who performs ACL reconstructions and has been a rationale for pursuing the double bundle technique. The concept is that the AM bundle should carry more tension in flexion and the PL bundle should carry more tension in extension. A doubled-over soft tissue graft in a single tunnel may restore reciprocal tensile behavior if the tunnel has been placed to avoid PCL and roof impingement and the centers of the graft bundles can be separated and appropriately oriented at the femoral and tibial tunnel apertures.

Double bundle ACL reconstruction is not without its challenges. The most common cause of failure of any kind of ACL reconstruction is improper bone tunnel position. The double bundle procedure, which is more complex than the single bundle technique, has more risk of misplaced bone tunnels. For example, dual tunnels can interfere with each other when they are not meticulously positioned. In particular, a poorly positioned PL tunnel may displace a subsequently formed AM tunnel too far anteriorly, resulting in roof impingement and potential graft rupture.

The double bundle procedure has other potential challenges. The greater complexity of double bundle repair may result in longer surgical time. Two separate grafts need to be prepared, four tunnels need to be prepared, and four separate fixation devices are required.

Suitable femoral fixation options may be limited. Currently, the EndoButton™ may be the most common femoral fixation device for a double bundle ACL reconstruction due to its low profile. Cross-pin femoral fixation may not be feasible for double bundle ACL reconstruction due to anatomical constraints in the vicinity of the femoral tunnel apertures.

A larger tibial footprint of a double bundle ACL reconstruction may offer greater potential for femoral notch impingement by the graft. Larger cross-sectional areas of graft tissue can traverse the intercondylar notch in a double bundle ACL reconstruction. This may result in PCL impingement as well as notch impingement due to the size of the grafts. PCL impingement has been seen even in single bundle ACL reconstructions. PCL impingement may occur when the tibial tunnel is placed in a vertical orientation at an angle >70 degrees from the medial joint line of the tibia and the femoral tunnel is then drilled through the tibial tunnel. Vertical placement of the ACL graft at the apex of the femoral notch may cause the graft to wrap around the PCL, which may cause high tension in the graft when the knee is flexed. High graft tension in flexion may cause the graft to stretch out or may prevent the patient from regaining full knee flexion. Preventing PCL impingement in single bundle ACL reconstructions requires a femoral notchplasty as well as placement of the femoral tunnel further down the sidewall of the intercondylar notch. PCL impingement may not be an issue with double bundle reconstructions, because the femoral tunnels may be placed in the anatomic footprint of the ACL through an inferomedial arthroscopic portal. However, when two femoral tunnels are separated by a bone bridge (often 2 mm wide), the composite area may extend outside the border of the anatomic ACL footprint. This effectively increases the cross-sectional area of the graft and “overstuffs the notch.” Furthermore, the cross-sectional area of the native ACL as it crosses the PCL is approximately 54.4 square mm, and may be significantly less in smaller people. Therefore, if double bundle ACL reconstruction with a standard size graft is performed with dual femoral and tibial tunnels, the effective cross-sectional area of the graft may exceed 100 square mm. Notch or PCL impingement, loss of knee flexion and eventual stretching and failure of the tissue may result.

Revision is also more difficult with double bundle ACL reconstruction than with single bundle ACL reconstruction. A significant volume of bone is consumed with a four tunnel technique. It may be problematic to place revision tunnels anatomically if there is no bone into which to drill. In order to ensure correct graft placement at the time of revision, a bone grafting procedure may be required to fill the vacant bone tunnels, followed by a second procedure to revise the ACL reconstruction.

Thus, there exists a need in the art for novel ACL reconstruction devices that provide the strength of cortical fixation, the stiffness of aperture fixation, and osteoconductivity for bony ingrowth to allow circumferential healing of the graft/tunnel interface. There also exists a need for a method of fixation that separates an ACL graft into bundles such that knee kinematics are restored without the need for separate bone tunnels and multiple soft tissue grafts. There also exists a need in the art for an ACL reconstruction technique that produces bone tunnels that more closely replicate the anatomic femoral and tibial ACL footprints, uses a single graft separated into bundles to restore the kinematics of the native ACL, and eliminates the problems of increased surgical time and complexity, difficult revision, notch impingement and PCL impingement that are inherent with the current double tunnel, double bundle ACL technique. There also exists a need in the art to provide a fixation implant that can be used to deliver specific therapeutic agents, such as biochemicals that allow for tendon to bone healing or enhance osteoinductivity such that bone may grow into the fixation implant.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure will now be discussed with reference to the appended drawings. It will be appreciated that these drawings depict only typical examples of the present disclosure and are therefore not to be considered limiting of the scope of the invention.

FIG. 1 is a perspective view of asurgical tool1 for inserting a tensioned ligament into a patient;

FIG. 2 is a cross-sectional side view of thehandle portion2 of thesurgical tool1 ofFIG. 1 with the cross-sectional plane taken parallel to the twoattachment members4,6 along their greatest width;

FIG. 3 is a cross-sectional side view of thehandle portion2 of thesurgical tool1 ofFIG. 1 with the cross-sectional plane taken between the twoattachment members4,6 and normal to the cross-sectional plane ofFIG. 2;

FIG. 4 is a perspective view of theproximal handle portion2 with the twist knob removed;

FIG. 5A is a perspective view of a ligament fixation system;

FIG. 5B is a perspective view of another ligament fixation system;

FIG. 6A is a perspective view of a fixation device; andFIG. 6B is another perspective view of the fixation device ofFIG. 6A from a different angle;

FIG. 6C is a perspective view of another fixation system;FIG. 6D is another perspective view of the fixation system ofFIG. 6C in an expanded configuration;

FIG. 7A is a perspective view of another fixation device; andFIG. 7B is a perspective view of the fixation device ofFIG. 7A in an expanded configuration;

FIG. 8A is a perspective view of yet another fixation device;FIG. 8B is a perspective view of the fixation device ofFIG. 8B in an uncoiled configuration; andFIG. 8C is a side cross sectional view of the fixation device ofFIG. 8A in an fixation system with a graft suspended in a bone tunnel;

FIG. 9A is a perspective view of yet another fixation system;

FIG. 9B is a perspective view of yet another fixation system;

FIG. 9C is a perspective view of yet another fixation system;

FIG. 10A is a side view of yet another fixation system;FIG. 10B is a perspective view of the fixation system ofFIG. 10A;

FIG. 11A is a perspective view of yet another fixation system; andFIG. 11B is a perspective view of the fixation system ofFIG. 11A in an expanded configuration;

FIG. 12A is a top view of yet another fixation device;

FIG. 12B is a top view of yet another fixation device;

FIG. 12C is a top view of yet another fixation device;

FIG. 13 is a perspective view of a tamp tool;

FIG. 14 is a perspective view of another tamp tool; and

FIG. 15 is a perspective view of a double drill guide.

DETAILED DESCRIPTION

In this specification, standard medical directional terms are employed with their ordinary and customary meanings. Superior means toward the head. Inferior means away from the head. Anterior means toward the front. Posterior means toward the back. Medial means toward the midline, or plane of bilateral symmetry, of the body. Lateral means away from the midline of the body. Proximal means toward the trunk of the body, or toward the user. Distal means away from the trunk of the body, or away from the user.

In this specification, a standard system of three mutually perpendicular reference planes is employed. A sagittal plane divides a body into bilaterally symmetric right and left portions. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions.

In this specification, standard knee anatomical terms are employed with their ordinary and customary meanings.

The systems, methods, and devices described herein may improve a surgeon's likelihood of matching an ACL graft to a natural ACL attachment area on a femur or tibia; improve graft fixation; reduce surgical time; and improve clinical outcomes.

As used in this specification with reference to one or more structures, the terms “engaged,” “engaged with,” “coupled,” or “coupled to,” can mean that the one or more structures are engaged (or coupled) with each other either directly, or through one or more intermediate members.

It will be understood that the terms “ligament” or “ligament graft” as used herein, include any type of ligament graft including, but not limited to: any artificial ligament graft, natural ligament graft, allograft, autograft, xenograft, tendon, etc.

The following disclosure focuses on ligament graft repair of the ACL ligament. However, it will be understood that the devices, systems, methods, and instrumentation disclosed herein can be used in other ligament repair applications including, but not limited to: Posterior Cruciate Ligament (PCL), shoulder, ankle, foot, elbow, wrist, fingers, hands, back, neck, arms, legs, hips, etc.

FIGS. 1-4 show various views of asurgical tool1 that facilitates both the preparation and insertion of aligament graft10 into a patient. Thesurgical tool1 can apply tension to theligament graft10 to keep theligament graft10 straight and close to a shaft, or elongatemember12 of thesurgical tool1 to help facilitate insertion of theligament graft10 into the patient. Thesurgical tool1 can also help prepare theligament graft10 for insertion into the patient by applying a tension force to theligament graft10 to help “exercise” theligament graft10 prior to insertion.

Exercising or “pre-stretching” a ligament graft reduces the likelihood of post-operative ligament creep. Ligament creep is the undesirable lengthening or “stretching-out” of the ligament graft after it is has been implanted in the patient. In order to reduce the likelihood of ligament creep, the surgeon will typically exercise the ligament graft by applying a constant tension force to the ligament graft for a period of time sufficiently long enough to stretch out the ligament such that any additional stretching results in little or no lengthening of the ligament. Typically, the surgeon will stretch out the ligament with one device, remove the ligament from the stretching device, and then use a second device to insert the ligament into the patient. Switching the ligament between two separate devices is inefficient; increases the duration of the surgical procedure; and increases the risk of surgical complications. Moreover, once the ligament graft is released from the stretching device, the ligament is free to relax and shorten again over time, thereby increasing the likelihood of reintroducing ligament creep. Thus, the surgeon has to try to insert the ligament graft into the patient as quickly as possible, hoping that the ligament remains sufficiently “exercised” that little or no creep occurs. Thesurgical tool1 shown inFIGS. 1-4 eliminates these problems by providing asingle tool1 that can be used to both exercise the ligament graft and insert the ligament graft into the patient while maintaining the ligament graft under tension throughout the entire procedure.

FIG. 1 shows thesurgical tool1 holding aligament10 under tension. In this example, a fixation device, oraperture plug14, is attached to the distal end ofelongate member12. Theligament10 can be wrapped around theaperture plug14 and connected toattachment members4,6 throughsutures20,22 engaged with each end of theligament10. Tension forces applied to theligament10 can be increased by rotating atwist knob8 in a first direction causing theshaft12 to move in the distal direction and stretching theligament10. Tension forces applied to the ligament can also be reduced by rotating thetwist knob8 in a second direction causing theshaft12 to move in the proximal direction allowing theligament10 to relax. In the example shown inFIG. 1, theaperture plug14 is also connected to a cortical fixation system which includes acortical fixation member16 and at least oneconnector18.

Continuing withFIG. 1, the distal end of theelongate member12 can have a fixation device attachment feature (not shown) adapted to receive thefixation device14, such as a protrusion configured for insertion into an aperture formed in thefixation device14. Alternatively, the fixation device attachment feature can be threading formed on theelongate member12 with complimentary shaped threading formed in theplug14. Theelongate member12 has alongitudinal axis44, as seen inFIG. 2. The cross-sectional area of theelongate member12 can be less than the cross-sectional area of thefixation device14 attached to theelongate member12, with both cross-sectional areas taken transverse thelongitudinal axis44.

Ahandle portion2 can also include an impact surface located on the proximal end of thesurgical tool1 configured to receive impact forces to help drive theaperture plug14 into the bone tunnel.

In other examples, a fixation device, oraperture plug14, may not be used. Instead, the distal end of theelongate member12 can include a notch or groove (not shown) to receive a portion of theligament10 for tensioning.

In another embodiment (not shown), one or more of theattachment members4,6 can translate in the proximal and distal directions relative to thehandle portion2 to apply tension to theligament10, instead of, or in addition to, theelongate member12 translating in the proximal and distal directions.

In another embodiment, thesurgical tool1 can include four attachment members (not shown) configured to tension twoligaments10 at the same time forming a “quadruple bundle” ACL repair graft.

A method of using thesurgical tool1 shown inFIGS. 1-4 will now be described in the context of repairing an ACL with theaperture plug14 inserted into the femur of the patient. However, it will be understood that this apparatus, system, and method can be applied in other ligament reconstruction procedures, as mentioned previously. A surgeon can obtain asuitable ligament graft10 and attachsutures20,22 to each end of theligament graft10 using known methods in the art, such as “whip-stitching.” The surgeon can also attach asuitable aperture plug14 to the distal end of theshaft12. In this example, theaperture plug14 also is attached to a cortical fixation system including acortical fixation member16 and at least oneconnector18. The surgeon can attach one end of theligament graft10 to theattachment member4 by inserting thesuture20 engaged with the end of the ligament graft, into a ligament graft attachment feature, such as aslit24, formed in theattachment member4. The surgeon can then wrap theligament graft10 around theaperture plug14 and connect the other end of theligament graft10 to theopposite attachment member6 by inserting thesuture22 into the ligamentgraft attachment feature24 formed in theopposite attachment member6. However, in other examples, the ligament can be engaged directly by the ligament graft attachment feature, which may be a clamping device to grab the ligament, or the ligament can wrap around the ligament graft attachment feature to secure the ligament to the attachment feature. The surgeon can then twistknob8 in a first direction causing theshaft12 to move in the distal direction to stretch theligament10. The surgeon can select how much tension force is applied to theligament graft10 as he/she rotates thetwist knob8. In one example, the surgeon can select about 22 pounds of tension force. The selected tension force can be applied to thegraft10 and maintained for a predetermined amount of time sufficient to “exercise” theligament graft10 and reduce or eliminate ligament creep. The surgeon can then insert the entire ligament graft system into the patient starting with thecortical fixation connector18. The surgeon can thread theconnector18 andcortical fixation member16 through a tibial bone tunnel (not shown), and then into a femoral bone tunnel (not shown) formed in the patient, until thecortical fixation member16 passes through the femoral bone tunnel. Theaperture plug14 and ligament graft follow the cortical fixation system as it is inserted, passing through the tibial bone tunnel and into the femoral bone tunnel. The surgeon can rotate thesurgical tool1 to orient the placement of theaperture plug14 within the femoral tunnel. The surgeon can also use impact forces transmitted through thehandle portion2 of thesurgical tool1 to force theaperture plug14 into the femoral bone tunnel. Once theaperture plug14 is at the desired location within the femoral bone tunnel, the surgeon can adjust the length of theconnector18 to remove any slack between thecortical fixation member16 and theaperture plug14. The surgeon can then attach thecortical fixation member16 to the cortical bone of the femur. This process is known in the surgical arts as “cortical fixation.” In this manner, theaperture plug14 becomes “suspended” within the femoral bone tunnel by the cortical fixation system. This process is known in the surgical arts as “suspensory fixation.” The surgeon can then release thesutures20,22 fromslits24 and remove thesurgical tool1. However, in other embodiments, the surgeon can remove theshaft12 of thetool1 through the proximal end of thesurgical tool1 leaving thesutures20,22 attached to thesurgical tool1. This allows the surgeon to maintain tension force on theligament10 during the remainder of the operation. The surgeon can then insert a suitable tibial plug (not shown) into the tibial bone tunnel to anchor theligament10 within the tibial tunnel. The surgeon can also use cortical fixation on the tibial cortical bone to “cortically-suspend” the tibial plug within the tibial bone tunnel.

The inner workings of thesurgical tool1 will now be explained with reference toFIGS. 2-4.FIG. 2 is a cross-sectional side view of thehandle portion2 of thesurgical tool1 ofFIG. 1 with the cross-sectional plane taken parallel to the two attachment members at theirgreatest width4,6.FIG. 3 is a cross-sectional side view of thehandle portion2 of thesurgical tool1 ofFIG. 1 with the cross-sectional plane taken between the twoattachment members4,6 and normal to the cross-sectional plane used to generateFIG. 2.FIG. 4 is an isometric view of theproximal handle portion2 with thetwist knob8 removed.

Twist knob8 can slide over and attach totranslator member32. Thetranslator member32 can have one or more ribs48 (seeFIG. 4) configured to fit in complimentary shaped slots or depressions formed in the interior surface of the twist knob8 (not shown). Thus, rotating thetwist knob8 will cause thetranslator member32 to rotate by imparting rotational torque forces on thetranslator member32 via the interface between the slots formed in thetwist knob8 and theribs48 of thetranslator member32. Thetwist knob8 can be reversibly attached to thetranslator member32 via retaining members or protrusions34 (seeFIG. 2) formed on thetranslator member32 that can “snap-fit” intoapertures50 formed in thetwist knob8, as thetwist knob8 slides onto thetranslator member32 during assembly. Thetranslator member32 can have threads33 (seeFIG. 4) formed on an inner surface of thetranslator member32 and configured to interact with complimentary shapedthreads31 formed on theplunger30. Thus, rotating thetwist knob8 andtranslator member32 assembly will cause theplunger30 to translate within theelongate chamber36 in either the proximal or distal directions. If thetwist knob8 is rotated in a first direction, theplunger30 will move in the distal direction. If thetwist knob8 is rotated in a second direction, theplunger30 will move in the proximal direction.

Alternatively, a ratcheting mechanism (not shown) can be used instead of rotating the plunger withthreads31,33. In this example, the surgeon can push theplunger30, or a member engaged with theplunger30, in the distal direction whereupon one-way ratcheting teeth (not shown) can prevent theplunger30 from moving backward in the proximal direction. In this manner, the ratcheting mechanism will allow the surgeon to apply and maintain tension forces on the ligament. A ratchet release mechanism (not shown) can also be used to selectively disengage the one-way ratcheting teeth, allowing theplunger30 to move in the proximal direction, releasing the tension forces applied to theligament10.

Continuing withFIGS. 2-4, theelongate member12 can have both aninner shaft40 and anouter shaft38. Theplunger30 can be engaged with the proximal end of theouter shaft38 through aplunger pin26 and theinner shaft40 can be free to slide back and forth within theouter shaft38. Atension member28, such as a spring, can be placed inside the proximal end of theouter shaft38, between thepin26 and the proximal end of theinner shaft40. Thespring28 pushes theinner shaft40 in the distal direction as theplunger30 andplunger pin26 move in the distal direction. When aligament10 is placed on thesurgical tool1, as shown inFIG. 1, theligament10 will resist theinner shaft40 moving in the distal direction, causing thespring28 to compress as theplunger30 advances in the distal direction, putting tension forces on theligament10 which are proportional to the amount ofspring28 compression.

Thespring28 can be chosen to exert a predetermined range of tension forces on theligament10. Theplunger30 can be translated far enough in the proximal direction such that thespring28 is not compressed between theinner shaft40 and thepin26, and little or no tension forces are transmitted to theligament10. However, as theplunger30 advances in the distal direction, thespring28 is compressed between theinner shaft40 and thepin26 forcing theinner shaft40 in the distal direction and applying tension forces on theligament10. The amount of tension force applied to theligament10 depends on how far the user chooses to translate theplunger30 in the distal direction by rotatingtwist knob8. In this manner, the amount of tension force applied to theligament10 varies from zero to a predetermined maximum force necessary to completely compress thespring28. In one example, thespring28 is chosen to exert a predetermined range of tension forces on theligament10 in the range of zero to about 22 pounds of force when thespring28 is completely compressed. However,different tension members28, or springs, can be chosen based on the particular application and range of tension forces desired.

Theplunger30 can be configured to continue translating in the distal direction even after thespring28 is fully compressed, imparting even greater tension forces on theligament10 above the maximum force of thespring28. Theinner shaft40 can also have adistal stop member42 which interfaces with theouter shaft38 to push theinner shaft40 further in the distal direction, irrespective of thespring28, to impart even greater tension forces on theligament10, as desired.

The inner andouter shafts40,38 can also be notched and held in place by a holdingmember46 residing within the notches formed in the inner andouter shafts40,38, as can be seen inFIG. 2. In this manner, the holdingmember46 can prevent the inner andouter shafts40,38 from rotating with respect thehandle portion2 and/or translating too far in the proximal and distal directions. The holdingmember46 can also prevent the accidental removal of theinner shaft40 from theouter shaft38.

Referring toFIG. 5A, aligament fixation system150 is illustrated.Ligament fixation system150 may include afirst fixation device152, asecond fixation device160, and aconnector170. One or more filaments (not shown) may also be included to help orient thesecond fixation device160, as it is passed through the bone tunnel. Thefirst fixation device152 may be an aperture plug, thesecond fixation device160 may be an extracortical button, and theconnector170 may be a flexible loop. Thefirst fixation device152 can be any style, size, or shape aperture plug. Thesystem150 may be implanted in a distal femur so that thebutton160 may rest on an extracortical surface of a femur, theplug152 may reside in a femoral bone tunnel near the original femoral attachment area of the anterior cruciate ligament, and theloop170 may connect thebutton160 to theplug152. Theloop170 tobutton160 connection and theloop170 to plug152 connection may resemble pulley connections. Theloop170 may be adjustable in length, and the adjustment may be made after thesystem150 has been implanted. For example, thebutton160 and/or plug152 may include features, such as slits or passageways, which interact with theloop170 to permit adjustment. One way or two way adjustment is contemplated. For example, theloop170 may be shortenable, and may be lockable to prevent lengthening. In another example, theloop170 may be lengthenable, and may be lockable to prevent shortening. In yet another example, theloop170 may be shortenable and lengthenable, and may be lockable once a desired length is achieved. Locking may be selectable or automatic.

In an alternate embodiment, theligament fixation system150 may include afixation device160, aconnector170, and a ligament graft attached directly to theconnector170 without an aperture plug. Thefixation device160 may be an extracortical button, and theconnector170 may be a flexible member. Thesystem150 may be implanted in a distal femur so that thebutton160 may rest on an extracortical surface of a femur. The graft may reside in a femoral bone tunnel and occupy the original femoral attachment area of the anterior cruciate ligament, and theconnector170 may connect thebutton160 to the graft by suspensory fixation. Thebutton160 may include a plurality ofapertures162 through which theconnector170 may be routed. Theconnector170 may be a line, suture, cord, cable, wire, filament, or the like. The way that theconnector170 is routed through thebutton160 may cause theconnector170 to behave as if connected to the button by one or more pulleys. Theconnector170 may be routed through thebutton160 to form a loop, which may be adjustable to lengthen and/or shorten the loop. Theconnector170 may include one ormore locking portions172 which may selectively or automatically lock theconnector170 once a desired length is achieved. The lockingportions172 may resemble a finger trap or a sliding knot, and may function to lock separate portions of theconnector170 together.

Referring toFIG. 5B, anotherligament fixation system110 is shown with aligament graft10. Afirst fixation device112 may include abody120 and atether130. Thebody120 may be an aperture plug with a pair of opposinggrooves122,124 in which thegraft10 rests in use. Thebody120 may include anaperture126 to receive thetether130. Thetether130 may flexibly connect thebody120 to theconnector170. For example, thetether130 may be a flexible loop threaded through theaperture126 and theconnector170.First fixation device112 may be used with theloop170,button160, andgraft10 in a manner similar to that described inFIG. 5A.

Referring toFIGS. 6A and 6B, anotherfixation device60 is shown in front and back perspective views. Thefirst fixation device60 may be an aperture plug which extends from a leadingend61 to a trailingend63. Thefirst fixation device60 may include a pair of opposinggrooves66 which extend between theleading end61 and the trailingend63. Thefirst fixation device60 may include opposing sets ofprotrusions62 between thegrooves66. Theprotrusions62 may be barbs, ridges, teeth, serrations, posts, ribs, or the like. One ormore apertures64 may extend through thefirst fixation device60. In use, thefirst fixation device60 may be implanted in a bone tunnel with theloop170 threaded through theaperture64 to connect thefirst fixation device60 to theextracortical button160. Thegraft10 may lie in thegrooves66 and theprotrusions62 may engage the bone tunnel. Thefirst fixation device60 may also be used without theloop170 orbutton160.

Referring toFIGS. 6C and 6D, yet anotherfixation device70 is shown. Thefirst fixation device70 may be an aperture plug system, and may extend from a leadingend72 to a trailingend74. Thefirst fixation device70 may include an expandingelement80, anexpander90, and anactuation element100. The expandingelement80 may be a sheath, a sleeve, a tube, or the like. Theexpander90 may be a wedge or the like. Theactuation element100 may be used to urge theexpander90 into engagement with the expandingelement80 to cause expansion of the expandingelement80. Theactuation element100 may pull, push, twist, or otherwise urge theexpander90 into engagement with the expandingelement80. In the example shown, theactuation element100 is a tension element such as a line, suture, cord, cable, wire, filament, or the like. Theactuation element100 may also be a compression element, such as a shaft or pole, or a torque element, such as a hex key. In use, thefirst fixation device70 may be implanted in a bone tunnel with thegraft10 resting againstopposite sides82,84 of thesleeve80. Thesuture100 may be pulled to draw thewedge90 inside thesleeve80, thus expanding the sleeve as shown inFIG. 6D and urging thegraft10 against the bone tunnel. The trailingcorners92 of thewedge90 may dig into thesleeve80 to prevent thewedge90 from working itself out of thesleeve80. Thewedge90 may also include other protrusions (not shown) which prevent backout. Thesleeve80 may be smooth or textured.

Referring toFIGS. 7A and 7B, yet anotherfixation device140 is shown.First fixation device140 may be another aperture plug which extends from aleading end142 to a trailingend144.Aperture plug140 may be at least partially split so that the trailingend144 bifurcates into two or morebendable legs141. Theaperture plug140 may include opposing sets ofprotrusions146 on outward facing lateral surfaces of the trailingend144. Anaperture148 may extend through theleading end142 and the two ormore legs141 may also be separated by anaperture143.Aperture plug140 may be at least partially formed from a flexible or resilient material so that the trailingend144 can assume a more closed configuration as shown inFIG. 7A, or a more open configuration, as shown inFIG. 7B.First fixation device140 may be used with theloop170,button30, and graft in a manner similar to that described forfirst fixation device20. In this arrangement, theloop170 may be threaded through theaperture148 and the graft may rest against theprotrusions146 so that the trailingend144 tends to urge the graft against the bone tunnel wall.

Referring toFIGS. 8A-8C, anotherfixation device180 is shown.Second fixation device180 may be described as an extracortical suspensory button.Button180 may be made of a flexible or resilient material that allows it to collapse to a smaller size and expand to a larger size. For example, thebutton180 is shown as a coiled structure which may have a closely packed configuration, shown inFIG. 8B, and an at least partially uncoiled configuration, shown inFIG. 8A. The uncoiled configuration may permit thebutton180 to slide lengthwise through a bone tunnel, while the packed configuration may permit the button to rest on an extracortical bone surface to support thegraft10 with aconnector190, as shown inFIG. 8C. Thebutton180 may be made of a metal or fiber mesh which is woven and coiled to provide the described configurations and functions.

Referring toFIG. 9A, acortical fixation system200 is illustrated.Cortical fixation system200 can include awasher230 and screw or screw construct (not shown). Thewasher230 may be described as an extracortical button and can have anaperture232 configured to receive the screw. The screw can be polyaxially pivotable with respect to thewasher230. Thesystem200 may be implanted in a proximal tibia so that thewasher230 may rest on an extracortical surface of the tibia and the screw may reside in a tibial bone tunnel which extends through an original tibial attachment area of the anterior cruciate ligament. Thewasher230 may include peripheral grooves ornotches234 to receive sutures (not shown) stitched to the ends of the graft. The sutures can be tied to thewasher230 by wrapping the sutures around thewasher230 in a variety of different patterns. The grooves ornotches234 can help engage the sutures to thewasher230.

Referring toFIG. 9B, anothercortical fixation system250 is shown similar to that inFIG. 9A. Thewasher280 can include anaperture270 configured to receive a screw (not shown). Thesystem200 may be implanted in a proximal tibia so that thewasher230 may rest on an extracortical surface of the tibia and the screw may reside in a tibial bone tunnel which extends through an original tibial attachment area of the anterior cruciate ligament. Thewasher280 may also includeapertures282 for receiving sutures (not shown) stitched to the ends of the graft. The sutures can be tied to thewasher230 by threading the sutures through theapertures282 formed in thewasher280 in a variety of different patterns. In this manner, theapertures282 can help engage the sutures to thewasher280.

Referring toFIG. 9C, yet anothercortical fixation system290 is shown similar to those above. Thewasher320 can include anaperture321 configured to receive a screw (not shown). Thewasher320 may include broad peripheral grooves ornotches322 to receive the ends of the graft and/or sutures (not shown). Thewasher320 may have aFIG. 8, bar, bowtie, or dogbone appearance. The sutures and/or graft can be tied to thewasher320 by wrapping the sutures around thewasher320 in a variety of different patterns. The grooves ornotches322 can help engage the sutures to thewasher320.

Referring toFIGS. 10A and 10B, yet anotherfixation system330 is shown. Thefixation system330 may include afirst fixation device340, a second fixation device (not shown), and aconnector350. Thefirst fixation device340 may be an aperture plug. The second fixation device may be an extracortical suspensory button or washer, as disclosed herein. Theconnector350 may include a threadedfastener364 which may be a self-tapping screw. Theplug340 may extend from aleading end342 to a trailingend344. Theplug340 may be at least partially split lengthwise so that the trailingend344 bifurcates. Theplug340 may include a portion which forms achamber346 to receive thefastener360. Theplug340 may form an aperture oreyelet348 near theleading end342. The second fixation device may include any of the features set forth for other washers in this disclosure. The washer may be polyaxially pivotable about a head of theconnector350. Theconnector350 may include a taper orwedge362, which may be integral with or formed separately from the threadedfastener364. Thetibial fixation system330 may be implanted so that the washer rests against an extracortical bone surface of the proximal tibia, theplug340 is in a bone tunnel which extends through an original tibial attachment area of the anterior cruciate ligament, and the graft (not shown) rests against side surfaces341,343 of the plug. As the threadedfastener364 is advanced into theplug340, thewedge362 forces the trailingend344 to expand and force the graft against the bone tunnel. However, expansion may be controlled in this system by limiting the threaded engagement with thechamber346 and/or by providing a thread relief. Furthermore, expansion may be limited when thewedge362 makes contact with the chamber.

Thefirst fixation device340 may be fabricated from polymer, metal, ceramic, bone, or other biocompatible material. In one example, thefirst fixation device340 may include a solid polymer portion and a portion formed from bone. The polymer portion may be polyetheretherketone (PEEK). The solid polymer portion may form at least part of theleading end342 and the bone portion may form at least part of the trailingend344.

Referring toFIGS. 11A and 11B, yet anothercortical fixation system370 is shown. Thecortical fixation system370 may include an expandingelement380, anexpander390, and anactuation element400. The expandingelement380 may be an aperture plug which is at least partially split lengthwise. Theexpander390 may be a wedge, cam, or the like. Theactuation element400 may be used to urge theexpander390 into engagement with the expandingelement380 to cause expansion of the expandingelement380. Theactuation element400 may pull, push, twist, or otherwise urge theexpander390 into engagement with the expandingelement380. In the example shown, theactuation element400 is a tension element such as a line, suture, cord, cable, wire, filament, or the like. Theactuation element400 may also be a compression element, such as a shaft or pole, or a torque element, such as a hex key. In use, thesystem370 may be implanted in a bone tunnel with the graft (not shown) resting againstopposite sides382,384 of theplug380. Thesuture400 may be pulled to draw thewedge390 inside theplug380, thus expanding the plug as shown inFIG. 11B and urging the graft against the bone tunnel. Thewedge390 may include protrusions (not shown) which prevent backout. Theactuation element400 may hold thewedge390 in place permanently. Theplug380 may be smooth or textured.

Referring toFIGS. 12A-12C,washers410,420, and430 are shown, respectively.Washer410 forms a portion of a full circle or oval, and includesperipheral notches412 around the circular portion. This may increase visibility and flexibility in surgical uses.Washer420 forms a full circle, and includes a largecentral aperture421 which is spanned by abar424. This may increase visibility of the graft and/or sutures. Thebar424 can also have anaperture422 formed therein and configured to receive a screw construct (not shown).Washer430 is circular or oval, and includesperipheral notches432. This may increase flexibility in surgical uses.Washers410,420, and430 may be used in place of other washers disclosed herein. Any of the washers disclosed herein may include features to permit adjustment and locking of a line, such as a suture, to the washer, such as nothches or grooves. In other examples (not shown), the washers can have one or more narrowing slits around the periphery of the washer. The narrowing slits can be open wider toward the outer periphery of the washer and narrow toward the inner portion of the washer. In this manner, the suture can be easily guided into the narrowing slit. The narrowing slits can also have a final width toward the inner portion of the washer that is less than or equal to the width of the suture, such that the suture becomes “wedged” or trapped in the narrowing slit and held in place by the narrowing slit. Any of the washers disclosed herein can have one or more narrowing slits around the periphery of the washer in place of, or in addition to the other features disclosed herein.

Referring toFIG. 13, an example of a bone tamp520 for shaping a bone tunnel is shown. The tamp520 can be cannulated and configured to receive a guide wire (not shown) to guide the tamp520 to the bone tunnel. The guide wire can be fed through aperture orcannulation528. The tamp520 may include ahandle522, ashaft524, and abody526. Thehandle522 may include a striking platform. In the example shown,additional cannulations527,529 are included. Thebody526 may have a cross-sectional shape that is oblong, bowtie shaped, figure eight shaped, dumbbell shaped, bicuspid epicycloid shaped, or Gerono lemniscate shaped. A cross-sectional area of thebody526, transverse to the longitudinal axis of theshaft524, can have a plurality of lobes (not shown) having a height and a width, wherein the height of the lobes is greater than the width of the lobes. The cross-sectional area of thebody526 transverse to the longitudinal axis can have a figure eight shape (not shown) with two lobes overlapping each other forming a pair of indentations (not shown). The pair of indentations can have at least one concave portion and at least one convex portion. Thebody526 can also include cutting surfaces (not shown) which protrude from the sides of thebody526 and configured to remove pieces of bone as thebody526 is advanced into the bone tunnel. Thebody526 can also have at least one recessed area (not shown) adjacent to the at least one cutting surface and configured to capture the removed portions of bone as the tool is advanced into the bone tunnel. Thebody526 can also have at least one aperture configured to facilitate removal of trapped bone portions. In use, the guide wire may be positioned in the bone relative to the bone tunnel. The guide wire may be received incannulation528 so that thebody526 slides into the bone tunnel along the guide wire. The tamp520 may be pushed or impacted into the tunnel to refine the size and/or shape of the tunnel to receive an implant. In another example of use, the guide wire may be received in one of theadditional cannulations527,529 to offset the tamp520 relative to the bone tunnel. In this example, the tamp520 may asymmetrically refine the size and/or shape of the tunnel.

Referring toFIG. 14, another example of a tamp550 is shown. The tamp550 may share some or all of the characteristics of the tamp520. The tamp550 may include a handle orimpact member551, ashaft554 and abody556. Thehandle522 may include a striking platform. Thebody556 may have a cross-sectional shape that is oblong, bowtie shaped, figure eight shaped, dumbbell shaped, bicuspid epicycloid shaped, or Gerono lemniscate shaped. The tamp550 can be cannulated552 and configured to receive a guide wire (not shown) to guide the tamp550 to the bone tunnel. A leadingportion558 of thebody556 may be reduced in size and/or may be shaped to fit an unmodified bone tunnel. The leadingportion558 may also be described as a guide tip. In use, the leadingportion558 may be easily introduced into the bone tunnel. The tamp550 may then be pushed or impacted to drive it further into the tunnel. The leadingportion558 may follow the bone tunnel to guide the tamp550 along the tunnel.

The preceding disclosure contemplates a single bone tunnel with a non-circular cross section. More specifically, the preceding disclosure contemplates a tunnel whose cross section is shaped like an oblong, a bowtie, a figure eight, a dumbbell, a bicuspid epicycloid, or a Gerono lemniscate, or another shape which has a length greater than its width and a narrowing or constricted midportion across its width. Other bone tunnels are also contemplated. For example, two separate bone tunnels are contemplated. The bone tunnels can be formed in the tibia, for example. The tunnels may be parallel, intersecting, or skewed. Parallel or skewed tunnels may be separated by a bone bridge. Separate tibial tunnels may facilitate independent tensioning of the AM and PL graft bundles at relevant knee flexion angles.

Referring toFIG. 15, an example of atibial drill guide560 is shown. Thedrill guide560 may include anarm570, afirst rail580, asecond rail590, afirst guide tube600, and asecond guide tube610. Thearm570 may include a workingportion572, which may include afirst loop574 which is pierced by anaperture575. The workingportion572 may also include asecond loop576 pierced by asecond aperture577, adjacent to thefirst loop574. The workingportion572 may be pressed against the tibial ACL attachment area so that thefirst loop574 is centered in the antero-medial bundle attachment area and thesecond loop576 is generally centered in the postero-lateral bundle attachment area. Alternatively, the entire workingportion572 may be generally aligned with and centered in the total tibial ACL attachment area. The workingportion572 may include a grip member, such as a spike or tooth (not shown) to dig into the tibial plateau. Thefirst rail580 may be arcuate. Thefirst guide tube600 may be carried on thefirst rail580 so that a centerlongitudinal axis602 of the guide tube always passes through a center point of theaperture575, regardless of the position of the first guide tube along the first rail. Thesecond rail590 may also be arcuate. Thesecond guide tube610 may be carried on thesecond rail590 so that a centerlongitudinal axis612 of the guide tube always passes through a center point of theaperture577, regardless of the position of the second guide tube along the second rail. Thesecond rail590 may be held at an angle with respect to thefirst rail580. The angle may be fixed or variable. For example, the first andsecond rails580,590 may be formed as a single part or rigidly fixed together. In another example, the first andsecond rails580,590 may be hinged together near thearm570. Thesecond guide tube610 may be held at an angle with respect to thefirst guide tube600. The angle may be fixed or variable. For example, the first andsecond guide tubes600,610 may move together along therails580,590 in a fixed relationship. In another example, the first andsecond guide tubes600,610 may each be independently movable along therails580,590. Thetibial drill guide560 may include means to ensure that theaxis602 always passes through the center of theaperture575 and theaxis612 always passes through the center of theaperture577, regardless of the magnitude of the angle.

Any of the fixation devices disclosed herein may be adapted for use in the femur, the tibia, or in other suspensory fixation applications, as mentioned previously.

Any of the devices described herein may be fabricated from metals, alloys, polymers, plastics, ceramics, glasses, composite materials, or combinations thereof. Different materials may be used within a single part.

Those skilled in the art will appreciate that various adaptations and modifications of the just described preferred embodiments can be configured without departing from the scope and spirit of the invention. Therefore, it is to be understood that, within the scope of the above description, the invention may be practiced other than as specifically described herein.

It should be understood that the present apparatuses and methods are not intended to be limited to the particular forms disclosed. Rather, they are intended to include all modifications, equivalents, and alternatives falling within the scope of the claims. They are further intended to include embodiments which may be formed by combining features from the disclosed embodiments, and variants thereof.

The claims are not to be interpreted as including means-plus-function or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively.

The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically.

The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more” or “at least one.” The term “about” means, in general, the stated value plus or minus 5%. The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.”

The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes” or “contains” one or more steps or elements, possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes” or “contains” one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. It is appreciated that various features of the above-described examples can be mixed and matched to form a variety of other alternatives. As such, the described embodiments are to be considered in all respects only as illustrative and not restrictive. Similarly, manufacturing, assembly methods, and materials described for one device may be used in the manufacture or assembly of another device. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (25)

The invention claimed is:

1. A tool for implanting a ligament graft in a patient comprising: a handle portion; an elongate member comprising: a proximal end engaged with the handle portion; and a distal end; and at least one attachment member; wherein the at least one attachment member is proximal the distal end of the elongate member, the at least one attachment member is configured to engage a first portion of at least one ligament graft, the distal end of the elongate member is configured to engage a second portion of the at least one ligament graft, wherein a tension force is applied to the at least one ligament graft between the first portion of the at least one ligament graft engaged with the at least one attachment member and the second portion of the at least one ligament graft engaged with the distal end of the elongate member, wherein the elongate member is translatable in the proximal to distal direction to selectively increase and decrease the tension force applied to the at least one ligament graft; a tension member configured to impart a user selectable tension force to the at least one ligament graft within a predetermined range of tension forces, wherein the tension member is a spring, wherein the predetermined range of tension forces is between about zero pounds of tension force and about twenty two pounds of tension force; and a knob configured to rotate in a first direction to increase the tension force applied to the at least one ligament graft and rotate in a second direction to decrease the tension force applied to the at least one ligament graft.

2. The tool ofclaim 1, further comprising a plunger engaged with the elongate member, the plunger configured to translate in a first direction to increase the tension force applied to the at least one ligament graft and translate in a second direction to decrease the tension force applied to the at least one ligament graft.

3. The tool ofclaim 2, further comprising a ratcheting mechanism between the plunger and the handle portion, the ratcheting mechanism configured to allow the plunger to translate in the first direction and prevent the plunger from translating in the second direction to allow the user to select and maintain a tension force applied to the at least one ligament graft.

4. The tool ofclaim 3, further comprising a ratchet release mechanism configured to selectively disengage the ratcheting mechanism and allow the plunger to translate in the second direction.

5. The tool ofclaim 1, wherein the elongate member further comprises an inner shaft and an outer shaft, wherein the proximal end of the inner shaft is engaged with the distal end of the spring and the proximal end of the outer shaft is engaged with the proximal end of the spring.

6. The tool ofclaim 5, wherein the inner shaft further comprises a distal stop member, configured to interact with the distal end of the outer shaft to apply a tension force greater than the predetermined range of forces.

7. The tool ofclaim 5, further comprising a holding member configured to prevent accidental removal of the inner or outer shafts from the handle portion, and prevent rotational movement of the inner or outer shafts with respect to the handle portion.

8. The tool ofclaim 1, wherein the distal end of the elongate member further comprises a fixation device attachment feature adapted to receive a fixation device.

9. The tool ofclaim 8, wherein the fixation device attachment feature comprises a protrusion configured to be at least partially inserted into the fixation device.

10. The tool ofclaim 8, wherein the fixation device attachment feature comprises threading configured to interact with complimentary shaped threading formed in the fixation device.

11. The tool ofclaim 8, wherein the elongate member has a longitudinal axis and the cross-sectional area of the elongate member is less than the cross-sectional area of the fixation device attached to the elongate member with the cross-sectional areas taken transverse to the longitudinal axis.

12. The tool ofclaim 1, wherein the distal end of the elongate member further comprises a groove for receiving the second portion of the at least one ligament graft.

13. The tool ofclaim 1, wherein the at least one attachment member is engaged with the handle portion.

14. The tool ofclaim 13, wherein the at least one attachment member further comprises at least one ligament graft attachment feature.

15. The tool ofclaim 14, wherein the at least one ligament graft attachment feature comprises a slit configured to receive a suture that is engaged with the at least one ligament graft.

16. The tool ofclaim 1, wherein the at least one attachment member is translatable in the proximal to distal direction to selectively apply and release the tension force applied to the at least one ligament graft.

17. A tool for implanting a ligament graft in a patient comprising: a handle portion; an elongate member comprising: a proximal end engaged with the handle portion; and a distal end, distal from the handle portion; a first attachment member engaged with the handle portion on a first side of the handle portion; and a second attachment member engaged with the handle portion on a second side of the handle portion; wherein the first attachment member is configured to engage a first portion of at least one ligament graft, the second attachment member is configured to engage a second portion of the at least one ligament graft, and the distal end of the elongate member is configured to engage a third portion of the at least one ligament graft, the third portion of the at least one ligament graft intermediate the first and second portions of the at least one ligament graft; wherein a first tension force is applied to the at least one ligament graft between the first and third portions of at least one ligament graft, and wherein a second tension force is applied to the at least one ligament graft between the second and third portions of at least one ligament graft, wherein the elongate member is translatable in the proximal to distal direction to selectively apply and release the tension force applied to the at least one ligament graft; a tension member configured to impart a user selectable tension force to the at least one ligament graft within a predetermined range of tension forces, wherein the tension member is a spring, wherein the predetermined range of tension forces is between about zero pounds of tension force and about twenty two pounds of tension force; and a knob configured to rotate in a first direction to increase the tension force applied to the at least one ligament graft and rotate in a second direction to decrease the tension force applied to the at least one ligament graft.

18. The tool ofclaim 17, wherein the elongate member further comprises an inner shaft and an outer shaft, wherein the proximal end of the inner shaft is engaged with the distal end of the spring and the proximal end of the outer shaft is engaged with the proximal end of the spring.

19. The tool ofclaim 18, wherein the inner shaft further comprises a distal stop member, configured to interact with the distal end of the outer shaft to apply a tension force greater than the predetermined range of forces.

20. The tool ofclaim 18, further comprising a holding member configured to prevent accidental removal of the inner or outer shafts from the handle portion and prevent rotational movement of the inner or outer shafts with respect to the handle portion.

21. The tool ofclaim 17, wherein the distal end of the elongate member further comprises a fixation device attachment feature adapted to receive a fixation device.

22. The tool ofclaim 21, wherein the fixation device attachment feature comprises a protrusion configured to be at least partially inserted into the fixation device.

23. The tool ofclaim 21, wherein the elongate member has a longitudinal axis and the cross-sectional area of the elongate member is less than the cross-sectional area of the fixation device attached to the elongate member with the cross-sectional areas taken transverse to the longitudinal axis.

24. The tool ofclaim 17, wherein the first attachment member comprises two ligament graft attachment features and the second attachment member comprises two ligament graft attachment features.

25. The tool ofclaim 24, wherein the two ligament graft attachment features of the first attachment member and the two ligament graft attachment features of the second attachment member comprise slits configured to receive sutures engaged with the at least one ligament graft.

Images